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The Great Cancer Hoax: The Brilliant Cure the FDA Tried Their Best to Shut Down...


Chump Bailey

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http://articles.mercola.com/sites/articles/archive/2011/06/11/burzynski-the-movie.aspx

Burzynski, the Movie is the story of a medical doctor and Ph.D biochemist named Dr. Stanislaw Burzynski who won the largest, and possibly the most convoluted and intriguing legal battle against the Food and Drug Administration in American history.

In the 1970’s, Dr. Burzynski made a remarkable discovery that threatened to change the face of cancer treatment forever. His non-toxic gene-targeted cancer medicine could have helped save millions of lives over the last two decades had his discovery not been criminally suppressed by the US government, as his therapy, called “antineoplastons,” have been shown to effectively help cure some of the most “incurable” forms of terminal cancer.

This documentary takes you through the treacherous 14-year journey Dr. Burzynski and his patients have had to endure in order to finally obtain FDA-approved clinical trials of antineoplastons.

His story is yet another testament that fact can be far stranger than fiction, as the film exposes the powerful, unscrupulous forces that work to maintain the status quo of the medical- and pharmaceutical industry at any cost—including the lives of millions of people.

Thought you might find interesting and a big reason why I despise the FDA.

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Thought you might find interesting and a big reason why I despise the FDA.

I suppose the American Cancer Society is in on it too?

And, here's how the research went:

Burzynski and Antineoplastons

Stanislaw Burzynski treats patients at a private clinic using what he terms antineoplastons, mixtures of peptides, amino acids, and other simple organic substances that are said to promote the body’s natural defenses against cancer. Although he has published several studies of his own, these are of a rather unclear design.7 A Phase II trial in glioma conducted under the auspices of the National Cancer Institute was halted due to poor accrual, after Burzynski failed to agree with the investigators on possible expansion of the eligibility criteria. Nine patients were accrued, six of whom were able to be evaluated for response. There were no objective responses, and all six showed evidence of tumor progression after treatment durations of between 16 to 66 days. The mean time to treatment failure (progression or discontinuation due to toxicity) was 29 days. All nine patients died before the study closed, all but one death being due to tumor progression. Although the authors of the article claimed that the small sample size precluded "definitive conclusions," the results of the patients in the trial are clearly extremely disappointing.8

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10 years ago, my freshman year at GMU, in my microeconomics class we had a very good lecture about the FDA. It related to opportunity cost or price vs. demand or something along those lines. The average time it takes for a new drug to pass FDA's testing is something like 10 years. Our professor showed us many examples of how many lives were actually lost because of FDA's extensive testing procedures. Millions and millions of lives have been lost because the FDA takes in excess of one decade to clear a drug for the public.

FDA's testing procedures also show you why there are really only a few major drug manufacturers. It can take decades before you actually turn a profit on a drug.

---------- Post added June-12th-2011 at 03:15 PM ----------

added, I don't really have anything against the FDA personally.

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I suppose the American Cancer Society is in on it too?

And, here's how the research went:

I don't think you have read far enough into it.

After the National Cancer Institute intentionally violated all protocols of their own antineoplaston trials, and after all state and federal agencies had failed in their 14-year campaign to remove Burzynski from society—after all of the dust settled—a profound truth began to emerge.

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10 years ago, my freshman year at GMU, in my microeconomics class we had a very good lecture about the FDA. It related to opportunity cost or price vs. demand or something along those lines. The average time it takes for a new drug to pass FDA's testing is something like 10 years. Our professor showed us many examples of how many lives were actually lost because of FDA's extensive testing procedures. Millions and millions of lives have been lost because the FDA takes in excess of one decade to clear a drug for the public.

FDA's testing procedures also show you why there are really only a few major drug manufacturers. It can take decades before you actually turn a profit on a drug.

---------- Post added June-12th-2011 at 03:15 PM ----------

added, I don't really have anything against the FDA personally.

The FDA is doing a much better job over the last 2 decades of getting treatments for things where people are at a high risk of death to clinical trials much faster.

When you look at the average, it is very misleading. How quickly do we want to bring the latest acne medicine onto the market? Or even something like high blood pressure, which certainly contributes to death, but for which there are multiple current treatments?

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The FDA is doing a much better job over the last 2 decades of getting treatments for things where people are at a high risk of death to clinical trials much faster.

When you look at the average, it is very misleading. How quickly do we want to bring the latest acne medicine onto the market? Or even something like high blood pressure, which certainly contributes to death, but for which there are multiple current treatments?

And they are plenty of pending lawsuits as a result. You sincerely believe it's about protecting the public and I absolutely do not. I do respect your opinion as always though.

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The FDA is doing a much better job over the last 2 decades of getting treatments for things where people are at a high risk of death to clinical trials much faster.

When you look at the average, it is very misleading. How quickly do we want to bring the latest acne medicine onto the market? Or even something like high blood pressure, which certainly contributes to death, but for which there are multiple current treatments?

10 years, though? I mean, damn, that seems like a ****load of time for testing. Obviously some have to be tested for long-term effects, but still, 10 years?

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It also doesn't help that a quick search on the writer of OP's article turns up the fact that he is a controversial alternative medicine nut who believes that sunscreen causes skin cancer, HIV does not cause AIDS, and microwave ovens alter foods in inherently dangerous ways.

His page on Quackwatch is pretty interesting, too: http://www.quackwatch.org/11Ind/mercola.html

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Pending law suits for what?

I could have made that clearer. There are plenty of lawsuits pending or that have been settled against drug manufacturers. The FDA is not interested in anything other than protecting profits. They're a lapdog for the pharmacuetical industry and nothing more.

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10 years ago, my freshman year at GMU, in my microeconomics class we had a very good lecture about the FDA. It related to opportunity cost or price vs. demand or something along those lines. The average time it takes for a new drug to pass FDA's testing is something like 10 years. Our professor showed us many examples of how many lives were actually lost because of FDA's extensive testing procedures. Millions and millions of lives have been lost because the FDA takes in excess of one decade to clear a drug for the public.

FDA's testing procedures also show you why there are really only a few major drug manufacturers. It can take decades before you actually turn a profit on a drug.

---------- Post added June-12th-2011 at 03:15 PM ----------

added, I don't really have anything against the FDA personally.

This isn't necessarily true, the FDA has a process for drugs that are needed in quicker order than others:

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

Fast Track, Accelerated Approval and Priority Review

Accelerating Availability of New Drugs for Patients with Serious Diseases

Speeding the development and availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or have advantages over existing treatments. The Food and Drug Administration (FDA) has developed three distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.

The following summary describes each element, how they differ, and how they complement each other.

Fast Track

Accelerated Approval

Priority Review

Comparison of Approval Times for Priority and Standard Review Drugs between 1993 and 2003

Fast Track

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases.

Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious diseases. However, diseases such as epilepsy, depression and diabetes are also considered to be serious diseases.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.

Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

Showing superior effectiveness

Avoiding serious side effects of an available treatment

Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome

Decreasing a clinically significant toxicity of an accepted treatment

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval

More frequent written correspondence from FDA about such things as the design of the proposed clinical trials

Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit

Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and

Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within

sixty days based on whether the drug fills an unmet medical need in a serious disease.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

click link for the rest

I can't copy it cleanly but note the table at the end of the page.

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It also doesn't help that a quick search on the writer of OP's article turns up the fact that he is a controversial alternative medicine nut who believes that sunscreen causes skin cancer, HIV does not cause AIDS, and microwave ovens alter foods in inherently dangerous ways.

His page on Quackwatch is pretty interesting, too: http://www.quackwatch.org/11Ind/mercola.html

Quackwatch has been defeated multiple times in court IIRC for defamation.

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How long did it take for them to create a drug and get it through the FDA for the symptoms of "restless leg syndrome" a totally manufactured "syndrome"? I think that for most things, the FDA, in the drug approving division, makes decisions to approve drugs based on the pharma industry's lobbyist activities. Anything that has real potential to actually cure something is held up in "testing" because the medico-pharma industry is such big business.

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The FDA is doing a much better job over the last 2 decades of getting treatments for things where people are at a high risk of death to clinical trials much faster.

When you look at the average, it is very misleading. How quickly do we want to bring the latest acne medicine onto the market? Or even something like high blood pressure, which certainly contributes to death, but for which there are multiple current treatments?

I am certain that you know much, much more on the subject than I do and I certainly do believe that the FDA is trying to do the best that it possibly can. We certainly need a watchdog like the FDA there to insure that drug companies aren't putting bogus drugs on the market. As I understand it, the testing was very, very relaxed and then there was a drug that was released that killed a bunch of people. The FDA wants to protect from something like that and this causes extensive testing (which takes time).

I think that FDA is here to protect us and that's exactly what they are doing. I don't have any idea of whether or not their testing procedures are too extensive.

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So if it is a mircale cure for cancer, why not develop it in countries in which the FDA has no jurisdiction?

seems to me a cure for cancer is needed worldwide, and given that there are better medical facilities outside the US it would stand to reason that someone else would have gone ahead with the research.

~Bang

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This isn't necessarily true, the FDA has a process for drugs that are needed in quicker order than others:

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

I can't copy it cleanly but note the table at the end of the page.

As I understand it, Fast Track exists specifically because the process of testing new drugs was taking an absurdly long amount of time. It's good to know that there is somewhere around a 6 month test period for Fast Track drugs. Looks like PeterMP was right and as best I can tell, Fast Track was instituted in 1992. It definitely seems that the FDA is doing a much better job at getting drugs to the people who need them than they once did.

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The founder of Quackwatch lost several defamation suits where he served as the plaintiff. That's neither here nor there, though. The information that is cited and linked on the page is more useful than the page itself.

I don't think it is personally.

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I don't think you have read far enough into it.

I prefer the information given by a peer reviewed journal specializing in cancer research over that of a secondhand summary of a propoganda documentary.

Maybe I'm just weird that way. :)

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For what purpose would the FDA quash a potential cure?

~Bang

They're in on it, you see. "It" being a vast conspiracy by the pharmaceutical companies to quash any cure of any disease, because it's more profitable to provide treatment of the symptoms.

Apparenty, the American Cancer Society is in on "it" too.

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